1. Field of the Invention
The present invention relates to devices, systems, and methods for delivering a pericardial reinforcement device onto the epicardium of a mammalian myocardium, more particularly, to devices, systems, and methods for minimally-invasively delivering an inflatable pericardial “sail” into the pericardial space for attachment to the myocardium.
2. Background
For many patients suffering from, e.g., cardiomyopathy, progressive dilation of the left ventricle of the cardial muscle, i.e., the heart, can precede an end-stage disease. Dilation renders the heart less efficient as it struggles to maintain contractile function. Moreover, the mechanical burden of adverse remodeling is thought to increase wall stress and, further, to impair cardiac function. This is particularly problematic when dealing with the left ventricle, which is the heart's pump.
The medical world has sought with some success to treat cardial dilation with medication. However, many of the medications include undesirable side effects. As a result, medications do not offer a long-term solution for all patients.
In recent years, those skilled in the art have sought mechanical means to prevent or constrict dilation. For example, the CorCap Cardiac Support Device™ manufactured by Acorn Cardiovascular, Inc. of Minnetonka, Minn. was the subject of a study published in December 2004. The study reported the results of 48 patients who, as part of open-heart surgery, underwent an invasive implantation of a restrictive, mesh-like device, which was wrapped around the patients' hearts to slow left ventricle dilation. The findings of the study suggest that, by applying a restrictive mechanical force around the heart, adverse left ventricle remodeling in patients with cardiomyoplasty can be stabilized and, possibly, can be reversed. One shortcoming of the CorCap and similar devices is the invasive nature of the procedure.
Therefore, it would be desirable to provide alternative minimally invasive, systems that will reduce risk and improve recovery time.